Critical Mistakes during Root Cause Investigation : Pharmaguideline

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Critical Mistakes during Root Cause Investigation

Root cause investigation is not an easy task in pharmaceuticals. An improper investigation may cause critical problems during the regulatory inspections.
Root cause analysis is a very frequently used tool in pharmaceutical industries to identify the cause of any deviation and determine the CAPA for GMP violations. Improper root cause investigation is commonly found in observations of regulatory inspections.

Improper root cause analysis is done because companies and employees don’t have proper knowledge of the root cause analysis. A problem or event requires enough effort in its analysis to reach to its real cause means it is required to dig out more than normal to find out the root cause.

Root Cause Investigation In most of the cases where an improper root cause analysis is observed, an easy and normal cause was considered as a root cause. For example, any problem in a tablet compression machine is mostly considered as “Human Error”. Where an investigation is closed after training of the operator. An insufficient investigation can’t remove the real cause after corrective and preventive action and the problem will occur again.

Sometimes the investigation is not done completely and stopped at a direct cause instead of identifying the root cause. A direct cause of any issue is easy to identify and everyone can see it directly without any brainstorming. The direct cause is directly related to the problem or incidence. While a root cause requires hard work and brainstorming to get identified. If the root cause is corrected then the same problem will never happen again in the future.

In the above example, where the root cause is identified as “Human Error” or “Operator Error” due to inadequate investigation, chipping of tablets occurred during the compression of the batch. A direct cause that operator runs the compression machine at maximum speed was considered as the root cause.

It could be further investigated to dig out the real root cause by asking more “Whys”. When further investigated it is found that the operator was not aware of the maximum speed of the machine for that product. Further investigation shows that the maximum speed of the compression machine at which machine could be run was not included in the batch manufacturing record. When it was further investigated, it was found that the highest speed of the compression machine was not included in process validation parameters and machine was not validated at the highest running speed.

In the above extensive investigation, we found that the “Human Error”, a direct cause is converted into a real root cause.

Effects of Insufficient Investigation during Root Cause Analysis
The main problem happens when the real root cause is not identified, the CAPA prescribed for the issue would not be prescribed for the real cause and root cause would not be solved. When the root cause remains unsolved, the same problem occurs again in the future.

During the identification of the actual root cause, a lot of probable and secondary causes are also identified. These probable causes help us to identify future problems easily.

The Way to Identify the Actual Root Cause
All the employees involved in root cause investigation must be aware of the direct cause and root cause. Employees must also be trained in digging down the causes to the bottom.

We need to go through a chain of causes to find out the actual root cause. There are many tools we can use to dig out the problem. As I had described in the previous article 5 why tool alone is not enough to find the real root cause. Which tool should be used for investigation, is a result of one’s experience and knowledge of the investigation process but fishbone tool and fault tree tool with “5 why” or “5 How” tool are effective to investigate a complex problem.
Related: 5 Why Tool for Investigation

Additionally, the root cause analysis is a time taking process and also required sufficient brainstorming therefore, the management and employees must invest sufficient time and manpower to get the best results.
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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